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End Stage Renal Failure on DialysisREACDNCT03905551

Impact of Cold Dialysis in Combination With Intradialytic Exercise in Aspects Related to Quality of Life and Health

A study testing Cold Dialysis, Typical Dialysis and Exercise in people with End Stage Renal Failure on Dialysis, run by University of Thessaly at 3 sites in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Despite the tremendous advances in dialysis technology, hemodialysis (HD) is a significant challenge for dialysis patients and quality of their lives[2]. Research has shown for years that dialysate fluid temperature and especially the typical dialysis (TD) temperature at (37°C) are complicated by hemodynamic… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
End Stage Renal Failure on Dialysis
What is being tested?
Cold Dialysis, Typical Dialysis and Exercise
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
3 sitesGreece
Study dates
1 Feb 2015to 28 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinically stable ESRD patients receiving regular hemodialysis treatment for at least 3 months,
  • adequate dialysis delivery Kt/V >1.1
  • good compliance of dialysis treatment
  • serum albumin >2.5 g/dL
  • hemoglobin ≥11g/dL.

Who cannot join

  • Patients with a reason to be in a catabolic state,
  • hyperthyroidism,
  • active vasculitis,
  • malignancies,
  • pregnancy
  • HIV,
Show all 14Show fewer
  • opportunistic infections,
  • musculoskeletal contraindication to exercise,
  • requirement for systemic anticoagulation,
  • participant or participated in an investigational drug or medical device study within 30 days,
  • active inflammations, that required intravenous antibiotics within 3 months prior to enrollment,
  • diabetics receiving insulin therapy,
  • New York Heart Association grade IV heart failure,
  • mental incapacity to consent.

Trial locations and contacts

3 sites in 1 country.

Greece3 sites

  • University Hospital of Larissa, Nephrology Clinic

    Larissa, Thessaly, 41110

  • Patsidis General Clinic

    Larissa, Thessaly

  • General Hospital of Trikala

    Trikala, Thessaly, 42100

Other trials in Greece

About this study

Official title: The Effect of Exercise Rehabilitation Regimes in Combination With Changes in Dialysis Procedures in Aspects Related to Quality of Life and Health in End Stage Renal Disease Patients

Despite the tremendous advances in dialysis technology, hemodialysis (HD) is a significant challenge for dialysis patients and quality of their lives[2]. Research has shown for years that dialysate fluid temperature and especially the typical dialysis (TD) temperature at (37°C) are complicated by hemodynamic instability which leading to an increased risk of heat-induced hypotension causing patient discomfort and increased mortality.

Cold dialysis (CD) is defined as the reduction of dialysis fluid temperature to 35-36°C, approximately 1°C below the typical dialysate temperature which ranges between 37-38°C. A number of studies have reported beneficial effects of CD on maintaining hemodynamic stability, minimizes hypotension and exerts a protective effect over major organs including the heart and brain. In addition, current evidence showed the protective effect of CD in cardiac performance during the dialysis session. As the investigators know until today cardiovascular mortality is an important issue for nephrologists that care for ESRD patients, however, many other benefits have been observed on patients' overall health and quality of life levels by used of CD.

Read more

The above-mentioned benefits of CD in the hemodynamic stability and the general quality of life of the patients are highlighted even further due to the ever-increasing adoption of intradialytic exercise programs. It has been well established that intradialytic exercise leads to benefits of physiological, functional, and psychological deterioration, which commonly accrues as a consequence of biological aging, catabolic illness, and a sedentary lifestyle, factors that may all contribute to the progressive decline of vitality and quality of life commonly observed in ESRD patients.

However, despite a strong rationale for the implementation of intradialytic exercise programs and the aforementioned benefits of CD, the separate and combined effects of these protocols in aspects related to quality of life and health in ESRD patients have not been investigated to date.

The aim of the current clinical study was to assess the effect of exercise rehabilitation regimes in combination with changes in dialysate temperature in aspects related to quality of life and health in end-stage renal disease patients receiving hemodialysis.

Read the detailed description

The primary aim of the clinical study was to investigate the combined effect of cold dialysis and aerobic exercise in aspects related to health. More specific:

  1. To investigate the thermoregulatory responses of hemodialysis patients under four different hemodialysis protocols.
  2. To assess the changes in muscular architecture and functional capacity in dialysis patients after 7 months of intradialytic exercise training.
  3. To assess the impact on insulin sensitivity and glucose disposal.
Being tested
Cold Dialysis, Typical Dialysis, Exercise
Keywords
cold dialysis, intradialytic exercise, insulin resistance, thermoregulation, muscle architecture, quality of life, fitness, fatigue, physical activity
Medical subject headings
Insulin Resistance, Fatigue, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cold DialysisProcedure or surgery

    Dialysate temperature reduced to 35oC for a period of 7 months.

  • Typical DialysisProcedure or surgery

    Dialysate temperature is set at 37oC for a period of 7 months

  • ExerciseProcedure or surgery

    Aerobic Intradialytic exercise training

Study groups in NCT03905551
Study groupRoleWhat they receive
Standard DialysisPlacebo comparatorPatients participated in a 7 months exercise trials receiving standard dialysis (at 37oC)
Receives: Procedure: Typical Dialysis; Procedure: Exercise
Cold DialysisExperimentalPatients participated in a 7 months exercise trials receiving cold dialysis (at 35oC)
Receives: Procedure: Cold Dialysis; Procedure: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Body Heat Storage

    Body Heat storage will be assessed during the 4 hours of dialysis under the two main conditions. Body Heat Storage is calculated in Watt

    Measured: Changes from baseline at 7 months

  2. Change in Insulin Resistance

    Insulin resistances will be assessed by an Oral Glucose Tolerance Test using the OGIS index

    Measured: Changes from baseline at 7 months

  3. Change in Muscle Size

    Muscle size will be assessed using Ultrasonography

    Measured: Changes from baseline at 7 months

Secondary outcomes (3)

  1. Change in Quality of life score

    Quality of life will be assessed using the Sort Form 36 questionnaire. The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and is consisted of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

    The eight sections are:

    • vitality
    • physical functioning
    • bodily pain
    • general health perceptions
    • physical role functioning
    • emotional role functioning
    • social role functioning
    • mental health

    Measured: Changes from baseline at 7 months

  2. Change in Functional Capacity

    Functional capacity will be assessed by the 6 min walking test

    Measured: Changes from baseline at 7 months

  3. Change in Daily Physical activity

    Daily physical activity will be assessed by a 7 day recall pedometer

    Measured: Changes from baseline at 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2019
  2. Study start1 Feb 2015
  3. Primary completion29 Jun 2018
  4. Study completion28 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
The current study is a randomized clinical trial lasting for 7 months. Hemodialysis patients, which fulfilled the inclusion criteria, randomly divided into two groups: a) typical dialysis with dialysate temperature at 37°C (TD+EX) in combination with aerobic intradialytic exercise training, b) cold dialysis with dialysate temperature at 35°C (CD) in combination with aerobic intradialytic exercise training (CD+ET). Patients enrolled by a research assistant assigned into the study while the order that the patients assigned to the first scenario was randomly using a computer random number generator.
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03905551
Sponsor's protocol ID
921-5/11/2014
Acronym
REACD
Status last verified
Sep 2021
First submitted
29 Mar 2019
Last updated
6 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Parnas I, Spira M, Werman R, Bergmann F. Micro-electrode studies of the giant fibres of the American cockroach. Electroencephalogr Clin Neurophysiol. 1969 Aug;27(2):221. No abstract available.

    PubMed 4184202

  • Krase AA, Flouris AD, Karatzaferi C, Giannaki CD, Stefanidis I, Sakkas GK. Separate and combined effects of cold dialysis and intradialytic exercise on the thermoregulatory responses of hemodialysis patients: a randomized-cross-over study. BMC Nephrol. 2020 Dec 2;21(1):524. doi: 10.1186/s12882-020-02167-z.

    PubMed 33267815

  • Krase AA, Giannaki CD, Ntoumas I, Stefanidis I, Karatzaferi C, Sakkas GK. Cold Dialysis Combined with Intradialytic Exercise Improves Insulin Sensitivity in Hemodialysis Patients: A Pilot Randomized Clinical Trial. Medicina (Kaunas). 2026 Jun 30;62(7):1268. doi: 10.3390/medicina62071268.

    PubMed 42512810

  • Krase AA, Giannaki CD, Flouris AD, Liakos D, Stefanidis I, Karatzaferi C, Sakkas GK. The Acute, Combined, and Separate Effects of Cold Hemodialysis and Intradialytic Exercise in Insulin Sensitivity and Glucose Disposal. ASAIO J. 2024 May 1;70(5):436-441. doi: 10.1097/MAT.0000000000002117. Epub 2024 Jan 23.

    PubMed 38261536

  • Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.

    PubMed 35018639

  • Krase AA, Terzis G, Giannaki CD, Stasinaki AN, Wilkinson TJ, Smith AC, Zorz C, Karatzaferi C, Stefanidis I, Sakkas GK. Seven months of aerobic intradialytic exercise training can prevent muscle loss in haemodialysis patients: an ultrasonography study. Int Urol Nephrol. 2022 Feb;54(2):447-456. doi: 10.1007/s11255-021-02931-6. Epub 2021 Jun 28.

    PubMed 34184202

Questions about this trial

What is this clinical trial studying?

A study testing Cold Dialysis, Typical Dialysis and Exercise in people with End Stage Renal Failure on Dialysis, run by University of Thessaly at 3 sites in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Body Heat Storage (time frame: Changes from baseline at 7 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03905551, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.

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